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Largely because of EPO, Amgen, which is based in Thousand Oaks, Calif., has become the world's largest biotechnology company.
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The placenta is also a source of EPO production, because EPO expression has been shown in various trophoblast subpopulations throughout gestation [ 55].
However, because over expression of Epo and the resulting high hematocrits will lead to a variety of clinical problems, Epo gene therapy must be carefully regulated.
Similarly, Transkaryotic undertook full clinical trials for its version of EPO because its production process was different from Amgen's.
In our patient, we believe that the expected anaemia was avoided because of the Epo overproduction by the granuloma.
Chronic infections like tuberculosis are usually accompanied by anemia because of lowered Epo production caused by cytokines such as tumor necrosis factor [ 15].
In breast cancer, a phase III study on the use of EPO was stopped because of increased mortality, tumour progression and increased incidence of thrombotic and vascular events [ 90].
The timing of EPO dilution is important because the company states that the concentration of polysorbate 20 contained in the drug solution is critical for the stability of EPO; if the concentration of this detergent is too low, EPO will quickly adsorb to the surfaces of the drug container and will not be available for administration.
These experiments are important because they suggest that the recent clinical detriment seen with the use of Epo is not due to its tumour growth effects or angiogenesis.
But Dr. David P. Steensma at the Mayo Clinic, who has reviewed studies of Epo safety, said the existence of Epo receptors on tumors had not been proved because the studies have been flawed.
Amgen is selling a new version of EPO called Aranesp.
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